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Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 17, 2006
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The Cleveland Clinic

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with irinotecan works in treating patients with metastatic kidney cancer.

Condition Intervention Phase
Kidney Cancer Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Overall response
  • Safety and efficacy

Secondary Outcome Measures:
  • Difference in response to therapy in patients with clear vs nonclear cell renal cell carcinoma

Enrollment: 9
Study Start Date: May 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the response rate in patients with epithelial (clear or nonclear cell) renal cell carcinoma (RCC) treated with gemcitabine hydrochloride and irinotecan hydrochloride.
  • Compare the response in patients with clear cell RCC vs nonclear cell RCC treated with this regimen.
  • Determine the toxicities of this regimen.

OUTLINE: This is an open-label study.

Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed epithelial renal cell carcinoma (RCC), including either clear cell or nonclear cell RCC
  • Strong clinical evidence or biopsy proof of metastases to a site or sites distant from the primary tumor
  • Measurable disease
  • No untreated or progressive CNS metastases


  • ECOG performance status 0-1
  • Life expectancy > 3 months
  • Absolute neutrophil count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin > 9.5 g/dL
  • Creatinine ≤ 1.8 mg/dL
  • Bilirubin < 1.5 mg/dL
  • Calcium < 11.5 mg/dL
  • ALT and AST < 3 times upper limit of normal
  • No history of any of the following:

    • Serious cardiac arrhythmia or cardiac arrhythmia requiring treatment
    • Congestive heart failure
    • Angina pectoris
    • Other severe cardiovascular disease producing limitations of physical activity (i.e., New York Heart Association class III-IV heart disease)
  • No other prior malignancy except for the following:

    • Basal cell or squamous cell carcinoma of the skin
    • Carcinoma in situ of the uterine cervix
    • Any malignancy treated with curative intent and in complete remission for > 3 years
  • No active peptic ulcer disease, inflammatory bowel disease, or chronic diarrhea
  • No local or systemic infections requiring IV antibiotics within the past 28 days
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


  • Recovered from prior hormonal therapy, radiotherapy, biologic therapy, or chemotherapy
  • No more than 3 prior therapeutic regimens for metastatic disease
  • No prior organ allograft
  • More than 28 days since prior major surgery requiring general anesthesia
  • More than 28 days since prior radiotherapy to control pain from skeletal lesions
  • More than 28 days since prior hormonal treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401128

United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Study Chair: Ronald M. Bukowski, MD The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00401128     History of Changes
Other Study ID Numbers: CASE-CCF-6695
P30CA043703 ( U.S. NIH Grant/Contract )
First Submitted: November 16, 2006
First Posted: November 17, 2006
Last Update Posted: April 20, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Cleveland Clinic:
clear cell renal cell carcinoma
recurrent renal cell cancer
papillary renal cell carcinoma
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors